drugset / Trial / NCT06742138

To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma

NCT06742138

Phase 3 Not yet recruiting 284 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double-blind, multicenter trial,parallel control designed to evaluate treatment with pomalidomide + QL2109 + dexamethasone compared with pomalidomide + DARZALEX FASPRO® + dexamethasone in the participants with relapsed or refractory Multiple Myeloma.

Timeline

Start
2025-01
Primary completion
2027-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Subject QL2109 Monoclonal antibody 1800 mg Subcutaneous
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral
Background Pomalidomide Other / unclassified 4 mg Oral

Indications